BinaxNOW COVID-19 Ag Card Home Test 195-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10811877011337), received between Jun 10, 2021 and Feb 10, 2022 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2022False Negative Result; False Negative Result

  THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, PCR CONFIRMATION TESTINGS GENERATED POSITIVE RESULT. CONSUMER CONFIRMED SHE WAS SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509514 ↗
• InjuryJan 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CONSUMER REPORTED THAT DURING A TESTING SESSION WITH THE BINAXNOW COVID-19 ANTIGEN CARD HOME TEST, THE CONSUMER "GOT INJURED AND STARTED BLEEDING." THE DATE THAT THIS EVENT OCCURRED IS UNKNOWN. THE SAMPLE TYPE WAS NOT PROVIDED. DUE TO THE ALLEGED EVENT, THE TEST RESULTS WERE STATED TO BE INCONCLUSIVE BY THE CONSUMER. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13361643 ↗
• InjuryJan 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A TESTING SESSION WITH THE BINAXNOW COVID-19 HOME TEST, THE PATIENT "GOT INJURED AND STARTED BLEEDING." THE DATE THAT THIS EVENT OCCURRED IS UNKNOWN. NO PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13266492 ↗
• MalfunctionJan 17, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD HOME TEST. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266468 ↗
• MalfunctionDec 20, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 HOME TEST PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB. THE INITIAL TEST PERFORMED ON (B)(6) 2021 GENERATED NEGATIVE RESULTS. REPEAT TESTING WAS PERFORMED ON (B)(6) 2021 GENERATING NEGATIVE RESULTS. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2021 GENERATING POSITIVE RESULTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13041634 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CONSUMER REPORTED AN INJURY WHILE TESTING WITH THE BINAXNOW COVID-19 AG SELF TEST. PER THE CONSUMER, THEY GOT INJURED AND STARTED BLEEDING DURING THE SESSION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12315054 ↗
• MalfunctionJun 10, 2021Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED A RESULT DISCREPANCY WITH THE BINAX NOW COVID-19 HOME TEST. THE CUSTOMER REPORTED HER PROCTOR INFORMED HER OF A POSITIVE RESULT WITH THE BINAX NOW COVID-19 HOME TEST. SUBSEQUENTLY, THE CUSTOMER RECEIVED NOTIFICATION OF A NEGATIVE RESULT. TO ADDRESS THE ISSUE, THE CORRECT TEST RESULT WAS SENT TO THE CUSTOMER. ALTHOUGH REQUESTED CLARIFYING INFORMATION COULD NOT BE PROVIDED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11978935 ↗